This release reports on a large clinical trial that studied the use of the drug Repatha in patients with atherosclerotic cardiovascular disease. Or, more accurately, it reports that the details of the results of that study will be revealed at a major scientific meeting more than a month from now.
While the release does mention the potential harms of the drug, it fails to provide any real data on the benefits of the drug, nor does it mention that the drug is very expensive, with a list price of $14,100 annually. It contains no statements or information from researchers involved in the study.
Our review of a related Reuters story suggests that Amgen’s efforts met with some success.
Atherosclerotic cardiovascular disease is a serious, often fatal condition worldwide and new drugs that could treat it effectively would be a welcome improvement in clinical care. But this release is troubling in that it’s touting results to be presented at an upcoming scientific meeting, more than a month in the future, and it provides little, if any, substantive information for readers.
It’s unusual to announce results and not include a source or a link to the results. When we contacted Amgen for copies of the study abstracts named in the release, the company declined, instead referring us to the American College of Cardiology (ACC), the sponsors of the upcoming meeting. The ACC informed us that the abstract for the FOURIER study is under embargo until the presentation time on March 17. It’s not unusual for sponsors of scientific meetings to have a strict media embargo on scientific study presentations.
This early release strikes us as an effort to frame the discussion about the drug’s benefits in the trial without providing the required background needed for assessment.
There is no mention of costs in this release. As noted above, the list price for Repatha is around $14,100 yearly. Based on a related Reuters story, perhaps fueled by this news release, some insurers have questioned the drug’s high price given that detailed evidence of its efficacy has been wanting. Readers deserve to know the costs of drugs being touted, especially when they are this expensive.
The news release doesn’t quantify any results from the trials it mentions, saying only that the trials met their primary and secondary endpoints.
One particular statement in the release — “Repatha was non-inferior to placebo for the effect on cognitive function.” — should win a prize for obfuscation, since it basically says that the effects of the drug in question were no worse than a placebo.
This release is fairly explicit in detailing the contraindications and adverse effects that arose during earlier drug trials. It’s also explicit in its statements about what isn’t known about this drug and its usage:
– The effect of Repatha on cardiovascular morbidity and mortality has not been determined.
– The safety and effectiveness of Repatha have not been established in pediatric patients with HoFH (homozygous familial hypercholesterolemia) who are younger than 13 years old.
– The safety and effectiveness of Repatha have not been established in pediatric patients with primary hyperlipidemia or HeFH (heterozygous familial hypercholesterolemia).
But while the release mentions the side effect data from earlier studies, it doesn’t provide any hard numbers on side effect rates from the current trial under discussion.
The statement that “the effect on cardiovascular morbidity and mortality has not been determined” appears to be at odds with the statement that Repatha “met its primary composite endpoint (cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or coronary revascularization) and the key secondary composite endpoint (cardiovascular death, non-fatal MI or non-fatal stroke).” If we’re confused, perhaps other readers would be, too.
The study itself is described as a “multinational Phase 3 double-blind, randomized, placebo-controlled trial in approximately 27,500 patients” which should provide high-quality evidence. However, the release really provides no evidence for readers, other than to state that the study reached its primary and secondary endpoints (as stated above), which offers little in the way of information readers could use to evaluate the drug’s usefulness.
The release does not appear to commit disease mongering. It also provides statistics on the number of people suffering from heart disease. The release would have been stronger had it noted which fraction of this group would likely be eligible for — or require treatment with — this medication.
It’s clear that the release was distributed by Amgen with only company officials quoted. The researchers involved in the study were not named, and the studies or abstracts not provided, so it is impossible to know if there are conflicts of interest.
The release makes clear that study volunteers were already receiving “optimized statin therapy,” and it makes a brief reference to “statins or other currently approved lipid-lowering agents” as alternatives.
The release states that Repatha combined with statin therapy was compared only to placebo with statin therapy — not to statins alone or other interventions used to limit atherosclerotic cardiovascular disease. There is no mention of exercise or diet, although concerning the latter, the release does state that the drug is an “adjunct to diet.”
It’s clear that Repatha is already on the market.
The release refers to the trial as a “landmark,” but doesn’t tell us what’s new about this trial and its sub-analyses, or what makes it significant.
The release does not appear to contain any unjustifiable language.